FDA 510(k)
Substantially Equivalent
🇺🇸 United States
CHOLESTEROL & HDL CHOL. PROCEDURE
K Number: K781165
·
Decision Jul 27, 1978
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
111
Review Days
15
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Basic Information
- Device Name
- CHOLESTEROL & HDL CHOL. PROCEDURE
- K Number
- K781165
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Data Medical Associates, Inc.
- Date Received
- July 12, 1978
- Decision Date
- July 27, 1978
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
Other Clearances by Data Medical Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K993098 | HDL-C/LDL-C CALIBRATOR, MODEL 1913-003 | Oct 8, 1999 | Substantially Equivalent |
| K971113 | DMA TRIGLYCERIDES PROCEDURES | May 29, 1997 | Substantially Equivalent |
| K961919 | DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE | Jul 1, 1996 | Substantially Equivalent |
| K955302 | SERUM BICARBONATE/CARBON DIOXIDE | Feb 29, 1996 | Substantially Equivalent |
| K955796 | IRON CALIBRATOR & CALIBRATION VERIFICATION SET | Feb 29, 1996 | Substantially Equivalent |
| K955300 | TOTAL BILIRUBIN PROCEDURE | Dec 20, 1995 | Substantially Equivalent |
| K952437 | DMA GLUCOSE HEXOKINASE U.V. PROCEDURE | Oct 3, 1995 | Substantially Equivalent |
| K946161 | DMA TOTAL CHOLESTEROL PROCEDURE | Aug 23, 1995 | Substantially Equivalent |
| K946354 | DMA UNSATURATED IRON BINDING CAPACITY PROCEDURE | May 8, 1995 | Substantially Equivalent |
| K946355 | DMA ALBUMIN PROCEDURE | Mar 1, 1995 | Substantially Equivalent |